This proposal requests continued financial support for the General Clinical Research Center (GCRC) at the University of Pittsburgh. Initiated at the inception of the national GCRC program, this GCRC's activity was substantially enhanced by moving into a new, tailor-designed facility dedicated to clinical research in Montefiore Hospital within the last grant cycle in 1992. Since moving to the new facility, the breadth of clinical research has expanded to new investigators, the number of active protocols has doubled, and utilization has increased five-fold. The Human Gene Transfer Application Laboratory active protocols has doubled, and utilization has increased five-fold. The Human Gene Transfer Application Laboratory (HGTAL) supports three active gene transfer protocols in the institution, and thirteen of the active protocols include positron emission tomography (PET) to measure functional end point measures. We request continued support for the discrete GCRC emission tomography (PET) to provide infrastructure support for the 140 current protocols within this proposal . In order to enhance the efficiency in operation within the central facility, we request funding for a nurse practitioner to help conduct protocols on normal volunteers and well patients, particular in studies where the principal investigator is a basic scientist or pharmacist. We also request continued support for our HGTAL, which has contributed to state-of-the-art gene therapy studies, and our nutrition support group. We propose to continued our innovative concept of CDMAS through a contract to a local computer software company with expertise in data management to have access to their experience through a contract for a virtual person. In addition, we request new funding for support for dedicated satellite facilities, one within an acute psychiatric care facility at Western Psychiatric Institute and Clinic (WPIC), and one focused on women's health, including midwifery, at Magee Womens Hospital. These satellites would permit clinical research currently not feasible within the central GCRC facility. We also request funds to support a new core facility, the PET radiochemistry laboratory (PETRCL), to provide chemical synthesis also request funds to support a new core facility, the PET radiochemistry laboratory (PETRCL), to provide chemical synthesis of PET radiochemicals to investigators throughout the institution. The GCRC provides an organized base for a Clinical Research Coordinator Network in the institution. The response has been gratifying with over 150 participating members and a regular seminar series and group newsletter. We request modest funding to provide administrative support to this activity. In summary, recent growth in activity on the GCRC reflects the strong research environment and extramural funding base within the University of Pittsburgh. The GCRC has the potential to provide valuable infrastructure support to this clinical research effort.
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